The solution of the present invention has at least three applications. The solution of the present invention may be used as a moisturizer and sprayed or otherwise applied to the area of the body frequently covered by a diaper or other such type of undergarment worn, for example, by an incontinent, for effectively preventing irritations of the skin such as dermatitis, bed sores and the like.
Additionally, the solution of the present invention may be applied to the teeth and dental work to effectively retard chewed food particulates from sticking thereto. As a result, the solution of the present invention aids in the prevention of dental caries.
Furthermore, when combined with a flavoring agent, the solution is an effective saliva substitute for alleviating the symptoms of xerostomia, commonly known as "dry mouth syndrome."
Xerostomia is a condition in which the salivary glands produce insufficient quantities of saliva. Lack of sufficient saliva causes discomfort which can, in some cases, be quite severe. Without saliva, the mouth burns and the throat and tongue can undergo radical changes. Teeth can decay rapidity and the tongue can become smooth, cracked and vulnerable to infection. Often, there is a loss of taste, and because saliva contains important digestive enzymes, there are often problems with digestion.
The mouth is one of the body areas most exposed to the external environment. Normally, mucous forms a continuous protective layer in the nose, mouth and throat. A patient suffering from xerostomia not only has decreased fluid in the mouth, but also an insufficient quantity of mucoproteins and mucopolysaccharides to hold fluid in contact with the cells and create a barrier to irritation and infection.
Cases of xerostomia may vary from mild, in which only slight dryness is experienced, to severe cases in which the patient will have serious problems with mastication, swallowing, digestion, speech, tooth decay, and the like. As noted in U.S. Pat. No. 4,438,100 to Balslev, et al., there are a number of causes of xerostomia, including the physiological (e.g., age, menopause, post-operative conditions, dehydration), as well as the psychic (nervousness). The reasons for mouth dryness may also be pharmacological (e.g., as a common side effect of many medications, including diuretics, antiarthritics, anticholinergics, anti-depressants, and oral inhalers). Because such medicaments are not curative but are used for long-term treatment, the dry-mouth side effect is long-term as well.
Anti-cholinergics act on the vagus nerve and their actions are readily predictable by considering the consequence of interruption of parasympathetic and sympathetic cholinergic nerve stimulation. These consequences include: decreased gastro-intestinal motility, decreased gastric secretion, dry-mouth, and drying of mucous membranes in general, etc. Thirst and difficulty in swallowing occur when the mouth and esophagus become sufficiently dry, and dry-mouth fosters oral ulcerations and dental caries. It appears the most logical treatment for the "drying" side effects would by symptomatic, and non-systemic. Systemic medications would be irregularly absorbed since the primary agent (anticholinergic) acts to retard gastric emptying.
Oral inhalers, although not necessarily anticholinergic, present a similar side effect profile. The constant pounding, especially by elderly or inexperienced users, of the aerosolized powder against the throat causes undue dryness of the oral cavity. The non-systemic pathway discussed above has proven beneficial here as well since this condition has been heretofore left largely untreated.
Parkinson's disease, chronic or acute diarrhea, and anti-cholinergic preparations to treat ulcers, colitis, irritable bowel syndrome, etc., also commonly cause dry-mouth as a side effect. Xerostomia may also result from radiotherapy. The most severe cases of xerostomia are caused by radiation therapy after head and neck surgery and by autoimmune diseases such as lupus, Sjogrens Syndrome, and rheumatoid arthritis. See, for example, P. C. Fox, et al., J. Am. Dental Assoc. 110:519-525 (1985).
Until recently, the treatments for xerostomia have had significant drawbacks. For example, symptoms of mild xerostomia can be somewhat alleviated by consumption of fluids, hard candy and throat lozenges. Because of the susceptibility of xerostomia patients to tooth decay and gum disease, however, the increased sugar intake associated with conventional candy and lozenges is likely to further accelerate tooth decay and/or gum disease in an affected patient. In addition, fluids or candy are typically not effective with more severe cases of xerostomia, nor do they provide long-lasting relief for even mild cases.
There are also a number of artificial salivas on the market which contain alcohol, mineral oils, glycerine, and combinations of polyethylene glycols. A number carboxymethylcellulose-base preparations are on the market as well, including those sold under the marks Orex.RTM. (Young Dental), Xero-Lube.RTM. (Scherer), MoiStir.RTM. (Kingswood Laboratories), and Salivart.RTM. (Westport Pharmaceuticals). Many patients find, however, that such preparations are PG,5 irritating or distasteful, and that their lubricating effect is of relatively short duration.
There has also been some experimentation with parasympathomimetic drugs, i.e., drugs that mimic the action of the parasympathetic nervous system which controls salivation. There have been reported dosage control problems with these drugs, however, as well as significant side effects.